BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3161691 · Received May 23, 2013

    Report

    Report Number
    3003793491-2013-00602
    Event Type
    Death
    Date Received
    May 23, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TREATING A PT, THE AUTOPULSE PLATFORM WAS POWERED ON AND DISPLAYED USER ADVISORY (UA) 2 MESSAGE. THE PLATFORM WAS UNABLE TO PROVIDE COMPRESSIONS. CUSTOMER SWITCHED TO MANUAL CPR. IT WAS REPORTED THAT THE PT EXPIRED THROUGH NO FAULT OF THE DEVICE. CUSTOMER TRIED THE DEVICE ON A MANNEQUIN AFTER THE CALL AND GOT THE SAME RESULTS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228209 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MANUAL CPR